Parkinson DiseasePark-IMPULSENCT03970239
Serotonin in Impulse Control Disorders in Parkinson's Disease
A study testing Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin) and Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin) in people with Parkinson Disease and Impulse Control Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Impulse Control Disorders
- What is being tested?
- Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin) and Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2019to 13 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1 Patients with Parkinson's disease and impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients presenting currently with impulse control disorders or having presented with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2 for one or more of the following items: eating behavior; compulsive buying; pathological gambling; hypersexuality) , following the diagnosis of Parkinson's disease
- Patients able to sign the consent document and willing to participate in all aspects of the study
- Patients with Parkinson's disease and without impulse control disorders
Show all 14Show fewer
- Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients not currently presenting with impulse control disorders and other hyperdopaminergic behaviors and not having ever presented with impulse control disorders
- Patients able to sign a consent document and willing to participate in all aspects of the study
- Group 2 : Healthy volunteers
- Subjects aged ≥ 30 and ≤ 80 years old
- Subjects not currently presenting with impulse control disorders or hyperdopaminergic behaviors and not having ever presented with impulse control disorders
- Subjects able to sign a consent document and willing to participate in all aspects of the study
Who cannot join
- Group 1 :
- Patients with Parkinson's disease and impulse control disorders
- Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- Patients not able to perform Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI)
- Patients presenting with other severe medical condition or other parkinsonian syndrome
- Patients treated with Deep Brain Stimulation or levodopa pump
Show all 24Show fewer
- Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Patients presenting with substance dependence, except for tobacco
- Patients with Body Mass Index ≥ 35kilogram/meters2 (kg/m2)
- Patients with Parkinson's disease and without impulse control disorders
- Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- Patients not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
- Patients presenting with other severe medical condition or other parkinsonian syndrome
- Patients treated with Deep Brain Stimulationor levodopa pump
- Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Patients presenting with substance dependence, except for tobacco
- Patients with Body Mass Index ≥35kg/m2
- Group 2 : Healthy volunteers
- Subjects with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- Subjects not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
- Subjects presenting with neurologic, psychiatric or other severe medical condition
- Subjects treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Subjects presenting with substance dependence, except for tobacco
- Subjects with Body Mass Index ≥35kg/m2
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Bron
THOBOIS STEPHANE
About this study
Official title: Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease
Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system.
The primary objective of this study is to investigate the cerebral functional alterations in the serotoninergic system in patients with Parkinson's disease and impulse control disorders using Positron Emission Tomography with highly specific radiotracers of serotonin transporter (SERT) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and of serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using [18 Fluorine]-altanserin ([18F]-altanserin), in comparison to patients with Parkinson's disease without impulse control disorders and healthy volunteers.
- Conditions
- Parkinson Disease, Impulse Control Disorders
- Being tested
- Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin), Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)
- Keywords
- Parkinson's disease, Impulse control disorders, Serotoninergic system, Positron Emission Tomography (PET)
- Medical subject headings
- Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)Drug
Imaging of the serotoninergic system with Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 4 Megabecquerel/kilogram (MBq/kg) of [11C]-DASB immediately prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 2.1 milliSievert (mSv).
On a separate day, subjects will receive a single intravenous administration of approximately 3.7 MBq/kg of [18F]-altanserin for 120 minutes prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 8.4 mSv.
Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)Drug
Imaging of the serotoninergic system with Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 3.7 Megabecquerel/kilogram (MBq/kg) of [18F]-altanserin 120 minutes prior to imaging using Positron Emission Tomography. The effective dose in human body is about 8.4 mSv.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease patients | Experimental | All study participants undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). [11C] -DASB is a highly specific PET radiotracer which binds to the serotonin transporter (SERT).
[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor. Receives: Drug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin) |
| Imaging of healthy volunteers | Experimental | All healthy volunteers undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [18F]-altanserin.
[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor. Receives: Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
Between-group difference of binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
Measured: 2-3 days
Secondary outcomes (17)
Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)
The Ardouin Scale of Behavior in Parkinson's Disease (ASBPD) evaluates hypo- and hyperdopaminergic behaviors and can also detect and quantify neuropsychiatric fluctuations by evaluating OFF-drug dysphoria and ON-drug euphoria. It is based on a semi-structured interview that encompasses the whole spectrum of behavioral spectrum from hypo-to hyperdopaminergic syndromes as well as non-motor fluctuations. The scale consists of 18 items addressing non-motor symptoms, grouped in four parts: general psychological evaluation, apathy, non-motor fluctuations and hyperdopaminergic behaviors. The rating in five points (0-4 from absent to severe) is carried out during a semi-structured interview. Open-ended questions introduce each item, allowing patients to express themselves as freely as possible. Close-ended questions permit the rating of severity and intensity.
Measured: 2-3 days
Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS)
The Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS) is designed to measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in Parkinson's Disease (PD). The QUIP-RS is administered with an instruction sheet that provides examples of the behaviors being assessed and a brief description of the categories for frequency (never [0] = not at all, rarely [1] = infrequently or 1 day/week, etc.). Scores for each Impulsive Compulsive Disorder (ICD) and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
Measured: 2-3 days
Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale)
The full version of the UPPS-P Scale is composed of 59 items, with 10-14 items per scale. Items are scored on a 4-point scale:
Agree Strongly = 1 Agree Some = 2 Disagree Some = 3 Disagree Strongly = 4
Higher values translate into higher levels of impulsivity. The results allow assessement of the patient according to five impulsive personality traits:
- Negative urgency: tendency to act rashly under extreme negative emotions
- Lack of Premeditation: tendency to act without thinking
- Lack of Perseverance: inability to remain focused on a task
- Sensation Seeking: tendency to seek out novel and thrilling experiences
- Positive Urgency: tendency to act rashly under extreme positive emotions
Measured: 2-3 days
Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is composed of four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications and includes 65 items. Each question has five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The overall progression of disability is given a score ranging from 0 = no disability 1= slight disability 2= moderate disability 3= high disability and 4= severe disability.
Measured: 2-3 days
Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory (BDI-II) is used to measure the severity of depression. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms:
- 0-13: minimal depression
- 14-19: mild depression
- 20-28: moderate depression
- 29-63: severe depression.
Measured: 2-3 days
Starkstein Apathy Scale (SAS)
For this scale, patients are asked to answer 14 questions, each of which is scored on a 4-point scale of 0-3, and apathy is rated as more severe as the total score (0-42) increases.
Measured: 2-3 days
State-Trait Anxiety Inventory -Y (STAI-Y)
The State-Trait Anxiety Inventory measures anxiety by assessing someone's state (S) and trait (T) anxiety at the same time. Its combined format consists of 40 questions. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels "right now, at this moment". The T- Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels "generally". In responding to the S-Anxiety scale, the subjects choose the number that best describes the intensity of their feelings: (1) not at all, (2) somewhat, (3) moderately, (4) very much so. In responding to the T-Anxiety scale, subjects rate the frequency of their feelings on the following four-point scale: (1) almost never, (2) sometimes, (3) often, (4) almost always. Each STAI item is given a weighted score of 1 to 4. Scores for both the S-Anxiety and the T-Anxiety scales can vary from a minimum of 20 to a maximum of 80 with higher scores correlating to higher anxiety.
Measured: 2-3 days
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS measures the subject's ability to experience pleasure (hedonic tone) and its absence (anhedonia). It consists of 14 items with 4 possible responses: Definitely Agree, Agree, Disagree, Definitely Disagree. A score from 0- 14 is possible (1 point for each response in the Disagree category and 0 points for each response in the Agree category). The higher the score the less the subject is able to experience pleasure.
Measured: 2-3 days
Temporal Experience of Pleasure Scale (TEPS)
Measure specifically designed to capture the anticipatory and consummatory facets of pleasure. It consists of 10 questions assessing anticipatory pleasure (TEPS-ANT) and 8 questions assessing consummatory pleasure (TEPS-CON) using a 6-point fixed choice response format ranging from 1 = very false for me to 6 = very true for me. The higher the score for each section, the more the subject experiences anticipatory pleasure and consummatory pleasure, respectively.
Measured: 2-3 days
Stop Signal Reaction Time (SSRT)
Stop Signal Task
Measured: 2-3 days
Discounting rate
27-item Monetary Choice Questionnaire: for each question, patients will choose between two different monetary values (a high monitary value versus a low monitary value) in order to determine the patient's level of impulsiveness.
Measured: 2-3 days
Proportion of premature responses
4 Choice Serial Reaction Time Task
Measured: 2-3 days
Polymorphism rs6313 (or T102C) of the serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor
Polymorphism rs6313 also called T102C or C102T is a gene variation, a single nucleotide polymorphism (SNP) in the human Hydroxytryptamine Receptor 2A (HTR2A) gene that codes for the 5-HT2A receptor. The SNP is a synonymous substitution located in exon 1 of the gene where it is involved in coding the 34th amino acid as serine.
Measured: 2-3 days
Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT)
Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT)
Measured: 2-3 days
Magnetic Resonance Imaging metrics: anatomical imaging
Anatomical imaging using a T1-weighted Magnetization-Prepared RApid Gradient-Echo (T1_MPRAGE) sequence for morphometry.
Measured: 2-3 days
Magnetic Resonance Imaging metrics: Diffusion Weighted imaging
Diffusion weighted imaging for Diffusion Tensor Imaging (DTI) and tractography
Measured: 2-3 days
Magnetic Resonance Imaging metrics: Resting State Functional Imaging
Resting State Functional Imaging for functional connectivity
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start13 May 2019
- Primary completion13 Feb 2022 (estimated)
- Study completion13 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane THOBOIS, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970239
- Sponsor's protocol ID
- 69HCL18_0012
- Other IDs
- 2019-000340-99, 2019
- Acronym
- Park-IMPULSE
- Status last verified
- Feb 2020
- First submitted
- 6 May 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03970239
- Acronym / sponsor ID
- Park-IMPULSE / 69HCL18_0012
- Conditions
- Parkinson Disease, Impulse Control Disorders
- Keywords
- Parkinson's disease, Impulse control disorders, Serotoninergic system, Positron Emission Tomography (PET)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 13 Feb 2022 (estimated)
- Study completion
- 13 Feb 2022 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system.
The primary objective of this study is to investigate the cerebral functional alterations in the serotoninergic system in patients with Parkinson's disease and impulse control disorders using Positron Emission Tomography with highly specific radiotracers of serotonin transporter (SERT) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and of serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using [18 Fluorine]-altanserin ([18F]-altanserin), in comparison to patients with Parkinson's disease without impulse control disorders and healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease patients | Experimental | Drug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)All study participants undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). [11C] -DASB is a highly specific PET radiotracer which binds to the serotonin transporter (SERT). [18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor. |
| Imaging of healthy volunteers | Experimental | Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)All healthy volunteers undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [18F]-altanserin. [18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Group 1 Patients with Parkinson's disease and impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients presenting currently with impulse control disorders or having presented with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2 for one or more of the following items: eating behavior; compulsive buying; pathological gambling; hypersexuality) , following the diagnosis of Parkinson's disease
- Patients able to sign the consent document and willing to participate in all aspects of the study
Key exclusion criteria (24 listed)
- Patients with Parkinson's disease and impulse control disorders
- Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
- Patients not able to perform Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI)
- Patients presenting with other severe medical condition or other parkinsonian syndrome
- Patients treated with Deep Brain Stimulation or levodopa pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)Imaging of the serotoninergic system with Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 4 Megabecquerel/kilogram (MBq/kg) of [11C]-DASB immediately prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 2.1 milliSievert (mSv). On a separate day, subjects will receive a single intravenous administration of approximately 3.7 MBq/kg of [18F]-altanserin for 120 minutes prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 8.4 mSv. | Drug | Parkinson's Disease patients |
| Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)Imaging of the serotoninergic system with Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 3.7 Megabecquerel/kilogram (MBq/kg) of [18F]-altanserin 120 minutes prior to imaging using Positron Emission Tomography. The effective dose in human body is about 8.4 mSv. | Drug | Imaging of healthy volunteers |
Primary outcome
Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
Time frame: 2-3 days
Between-group difference of binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
17 secondary outcomes
Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)
Time frame: 2-3 days
Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS)
Time frame: 2-3 days
Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale)
Time frame: 2-3 days
Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 2-3 days
Beck Depression Inventory II (BDI-II)
Time frame: 2-3 days
Starkstein Apathy Scale (SAS)
Time frame: 2-3 days
State-Trait Anxiety Inventory -Y (STAI-Y)
Time frame: 2-3 days
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: 2-3 days
Temporal Experience of Pleasure Scale (TEPS)
Time frame: 2-3 days
Stop Signal Reaction Time (SSRT)
Time frame: 2-3 days
Discounting rate
Time frame: 2-3 days
Proportion of premature responses
Time frame: 2-3 days
Polymorphism rs6313 (or T102C) of the serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor
Time frame: 2-3 days
Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT)
Time frame: 2-3 days
Magnetic Resonance Imaging metrics: anatomical imaging
Time frame: 2-3 days
Magnetic Resonance Imaging metrics: Diffusion Weighted imaging
Time frame: 2-3 days
Magnetic Resonance Imaging metrics: Resting State Functional Imaging
Time frame: 2-3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane THOBOIS, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin) and Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin) in people with Parkinson Disease and Impulse Control Disorders, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane THOBOIS, PhD (4 72 35 72 18 ext. 33, stephane.thobois@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB) (time frame: 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.